EP2180824B1 - Dispositif de test de tolérance au glucose, procédé et utilisation - Google Patents

Dispositif de test de tolérance au glucose, procédé et utilisation Download PDF

Info

Publication number
EP2180824B1
EP2180824B1 EP08788413.6A EP08788413A EP2180824B1 EP 2180824 B1 EP2180824 B1 EP 2180824B1 EP 08788413 A EP08788413 A EP 08788413A EP 2180824 B1 EP2180824 B1 EP 2180824B1
Authority
EP
European Patent Office
Prior art keywords
test
data
sample
glucose tolerance
user
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP08788413.6A
Other languages
German (de)
English (en)
Other versions
EP2180824A1 (fr
Inventor
James Jackson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SmartSensor Telemed Ltd
Original Assignee
SmartSensor Telemed Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SmartSensor Telemed Ltd filed Critical SmartSensor Telemed Ltd
Publication of EP2180824A1 publication Critical patent/EP2180824A1/fr
Application granted granted Critical
Publication of EP2180824B1 publication Critical patent/EP2180824B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150847—Communication to or from blood sampling device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/11—Automated chemical analysis
    • Y10T436/115831—Condition or time responsive
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
    • Y10T436/143333—Saccharide [e.g., DNA, etc.]
    • Y10T436/144444—Glucose

Definitions

  • the invention relates to a glucose tolerance test device and to a method of use therefor, and in particular to a device adapted to simplify administration of a predetermined glucose tolerance test protocol, for example to facilitate domestic use without the requirement for direct clinical supervision.
  • a patient is required to fast for a period, for example overnight, before commencement of the protocol.
  • the patient then typically attends a medical centre where, under clinical supervision, a first blood test is taken, and passed for analysis and the results recorded.
  • a first blood test is taken, and passed for analysis and the results recorded.
  • the patient is then given a glycaemic load to ingest, for example in the form of a drink or solid food stuff adapted to deliver a predetermined glycaemic load.
  • a second blood sample is taken and analysed in similar manner to the first blood sample, and the results recorded. Further blood samples after further time periods may also be taken. In general, it is desirable that the patient minimizes movement and physical activity between test samples.
  • a comparison of the results of the respective blood samples, and in particular the glucose levels therein, taken together with the time periods and other data for example concerning the glycaemic load, may be used to determine the glycaemic status of the patient in familiar manner.
  • a normal glucose tolerance test protocol involves supervision by a medical practitioner, and for example attendance at a medical centre, at least for the taking of blood before and after ingestion of the glycaemic load, and for the development and analysis of the results, which typically involves a more detailed consideration of a broader range of parameters than might be the case for a single simple routine glucose test carried out domestically.
  • This requirement for the protocol to be practitioner led, and in many instances to be carried out at a medical facility can be a source of inconvenience for patients and healthcare professionals and limits the resources available to perform the test.
  • US Patent 4,731,726 describes a patient-operated glucose monitor and diabetes management system including means for measuring blood glucose and including means for inputting patent data, transmitting and receiving data to and from the monitor.
  • a reflectance photometer within the device measures blood glucose concentration by use of separate blood glucose strips inserted into a strip guide.
  • a test data collection device for testing glucose tolerance comprising: a test zone having a means to receive at least first and second blood test samples spaced apart by a predetermined time interval; a timer to measure such a time interval, and for example to measure elapsed time after collection of a said first sample; an indicator to indicate at least that a second test is due, operatively linked to the timer so as to make such indication after a lapse of a predetermined time interval; a data collector to collect data from the test zone in relation to each test sample; a data register to store data in relation to each test sample, in data communication with the said data collector; and wherein said test zone is adapted by provision of a plural of integral sample collection areas for receiving at least two blood samples over at least one predetermined specified time interval for analysis by the said data collector.
  • the device of the invention is specifically adapted to implement a particular glucose tolerance testing protocol and to collect data in accordance with the protocol.
  • An example protocol is described hereinafter by way of illustration of the device.
  • a user first fasts for a specified time period, for example at least eight hours fasting overnight, as specified by instructions accompanying the glucose tolerance test device of the invention and/or on the instruction of an advising medical or other supervising practitioner.
  • the user then obtains a blood drop sample, for example via a finger prick test by means of a lancet in familiar manner, and adds this sample to a test zone.
  • the data collector collects data concerning the sample in the test zone, and this is communicated to the data register for storage.
  • the user then ingests a standardised glycaemic load for example in the form of a glucose drink.
  • the timer of the device of the invention is adapted to measure an elapsed time interval and to function co-operatively with the indicator to indicate at least, expiry of this time interval.
  • the timer may be adapted to mark commencement of the predetermined time interval and begin to measure the same automatically on performance of the first test when a first blood sample is placed in a test zone.
  • means may be provided to allow the user to start the process of timing the predetermined interval, for example by means of a user operable start control, such as a start button.
  • This alternative is particularly preferred, since it gives a user flexibility over timing. For example a user may start the timing process on ingestion of the standard glycaemic load, the button thus constituting a "confirm glycaemic load ingestion" button and/or a user may start the timing process from the blood spot addition.
  • the user waits the predetermined time interval before performing at least one further blood test.
  • the indicator acts in conjunction with the timer to provide an indication at least on expiration of the predetermined wait time and thus an indication that the next test is due.
  • the user obtains a second blood drop sample, in similar manner to the first, and supplies this to a test zone on the glucose tolerance test device.
  • a user may obtain further blood samples in the manner of the first blood sample and add each blood sample in turn to a test zone on the glucose tolerance test device.
  • the user waits for a suitable test time until the glucose tolerance test device has concluded a test procedure.
  • the test device may include a test completed indicator, or the requirements for the test to be concluded may be provided in accompanying instructions.
  • the test protocol is then complete.
  • the device of the invention facilitates performance of a glucose tolerance test protocol in a simple compact device which is adapted to take a standard routine finger prick blood spot and which is adapted to guide a user through the most necessary steps of the protocol.
  • a simple compact device which is adapted to take a standard routine finger prick blood spot and which is adapted to guide a user through the most necessary steps of the protocol.
  • the device enables a user to perform a basic glucose tolerance test protocol and collection of the test data at home and without direct clinical supervision with little more difficulty than the user will be familiar with from routine blood glucose level tests.
  • the process is much simplified.
  • the ability offered by the invention to perform a simple but still reasonably representative glucose tolerance test protocol in a domestic environment offers similar advantages to those offered by simple blood glucose level tests, reducing the time taken and the clinician involvement at the initial data collection stage of procedure.
  • the timer is adapted at least to measure a specified first time predetermined interval in order to work in conjunction with the indicator to indicate when a second test is due.
  • this time interval may commence automatically when a first sample is placed in a sample collection area, or may commence in response to a user input, for example input by a user once the glycaemic load has been consumed.
  • an optional featue of the device is that the user may also indicate that the drink has been taken, for example by depressing the confirmation button, but that this will not be registered as the commencement time, rather it will only serve to provide the user with a way of confirming that the glycaemic load has been consumed.
  • the timer additionally measures at least a first elapsed time between performance of the first test, when a first sample is placed in a sample collection area, and/or when the time interval start control is actuated and performance of the second test, when a second sample is placed in a sample collection area.
  • the timer is in data communication with the data register which is further adapted to store such time interval data.
  • a test zone includes a means to detect the presence of a sample in a sample collection area, and thus to indicate when a test is performed.
  • a timer may measure one or more specified predetermined further time intervals and/or one or more further elapsed times as the case may be.
  • the or each predetermined time interval may be preloaded into a memory register within the device, or may be input by suitable input means. These may be set by a clinician or other supervisor of the protocol at the outset, or may be user settable, for example in accordance with such a supervisor's instructions or otherwise.
  • a parameter being pre-settable or being suitable for input it will be appreciated that this could be done by a supervising clinician or other supervisor, or by an end user.
  • the device of the invention may be provided with, or adapted to be placed in data communication with, a suitable input means.
  • any such parameter may be inherently pre-set in a memory register comprised as a part of the device.
  • a test zone is adapted for the collection of at least two successive samples over at least one predetermined specified time interval, and optionally of a larger plurality of successive samples spaced apart by a plurality of predetermined intervals.
  • a test zone includes one or more sample collection areas for receiving a blood sample for analysis by the data collector.
  • a sample is a blood sample, and in particular a pin prick blood sample for example produced by a finger prick procedure.
  • a sample collection area therefore preferably comprises a sample collection well to retain such a fluid sample in situ during performance of the test in fluid communication with a suitable means to provide for data collection.
  • a sample collection well for example comprises an apertured or structured portion in a device body defining a receptacle structure into which a sample can be received and retained for testing.
  • a sample collection well constitutes a circular aperture or structure in the body of the device defining such a sample retention area.
  • the sample retention area may include a layer of absorbent material into which the sample can be absorbed in situ during performance of the
  • the device preferably includes one or more sample analysers.
  • a sample analyser is provided in association with (e.g. in fluid communication with) a test zone.
  • a sample analyser may be located in a test zone.
  • a sample analyser is for example an electrochemical biosensor, and may for example be of similar construction similar to those electrochemical biosensors used in test strips supplied with conventional glucose meters.
  • a plurality of detachable sample collection modules may be provided, one for each sample to be collected, initially as an integral part of the device of the invention but adapted to be detached, for example for hygiene reasons, once a sample has been processed on the sample collection area and data therefrom collected by the data collector.
  • the indicator in the device of the invention indicates at least that a predetermined time interval has completed, and that it is therefore time to perform a subsequent blood test in accordance with the protocol.
  • the indicator may comprise an audio and/or a visual indication of the expiry of this time limit. More preferably, the indicator also provides an indication of the lapse of time as the time limit progresses, for example in some form of countdown. This may take the form of alphanumeric display, successive lights indicating progression of a time interval, electronically sensitive ink strips indicating progression of a time interval, or any other suitable combination.
  • the indicator is an audiovisual display and a visual display is given of the progress of the time interval and an audio alarm is given on its expiry.
  • the indicator may be further adapted to give other indications, and for example to indicate the completion of a particular step, such as the completion of an individual test.
  • a data collector is provided to collect data concerning the sample in use in a sample collection area, and in particular to collect data concerning the following: timing information relating to the addition of samples to the test device, for example the time and date, the temperature of the test device or its environment at the time of performing tests; test signals relating for example to the concentration of glucose in a test sample.
  • Said test signals may be varied in nature, for example test signals may relate to electrical current, potential or capacitance, or may be optical, for example fluorescence.
  • an equivalent plurality of data collectors may be provided each in data communication with a single such zone or area, or the device may be adapted for a single data collector to analyse each zone or area successively as each test is performed.
  • a data register is provided to collect at least data from the data collector.
  • the register also stores additional data associated with the test procedure.
  • the data register may store data collected by the timer concerning time intervals between tests etc.
  • the data register may record the time and/or the date of an event in which the test was commenced, or a particular stage of the test protocol was carried out.
  • the data register may record the time and/or date that the test was commenced, the time and/or date of the addition of a first blood sample, the time and/or date when an actuation of a time interval control indicating consumption of the glycaemic load was made, the time and/or date indicating the addition of a second blood sample, the time and/or date of the addition of one or more further blood samples, relevant secondary data concerning each test procedure performed using the test zones of the glucose tolerance test device, for example recording test signals at predetermined time intervals, such as microamps each second for 20 seconds, recording the temperature of the test device of the time when each test signal reading was obtained etc.
  • the device may include a clock/calendar means, or the date and/or time may be input by a user.
  • the device may include a temperature measuring and recording means, or the temperature may be input by a user.
  • a user identification may be stored in the device which can be entered either by the user or by a medical practitioner.
  • a device of the invention may include, or be adapted to facilitate the download from the data register of data into, a suitable processing means to process the raw data collected by the data collector and stored in the data register, in order to effect calibration of the device and/or obtain clinically meaningful data, and for example diagnostic data, therefrom.
  • the raw test data When the raw test data is collected, it should be calibrated using a specific algorithm which uses for example raw sensor data and temperature data. This can be done on the device but preferably is done externally in a separate instrument or database using a calibration algorithm matched to the particular device's data set. In an embodiment of the device in which the raw data is processed on-board the device to produce a test result, the result is stored within the device for display to the user and/or for upload to a remote database or the like.
  • a specific algorithm which uses for example raw sensor data and temperature data. This can be done on the device but preferably is done externally in a separate instrument or database using a calibration algorithm matched to the particular device's data set.
  • the result is stored within the device for display to the user and/or for upload to a remote database or the like.
  • the device is adapted both to collect data in a simple domestic environment under non-expert use and to allow the data to be readily passed to a clinical supervisor for processing.
  • the device is provided in two parts, comprising a data collecting part including at least the test zone and for example also the data collector, and a recording part including at least the data register, the two parts being in data communication, but the data recording part being detachable from the data collecting part after use.
  • the data recording part can be kept relatively small, and can be readily transported to a remote site for retrieval of data, while the data collecting part can be adapted either for reuse or discard.
  • the recording part is selectively sized and shaped to facilitate handling and transport of the recording device to the relevant processing facility.
  • the above embodiment relates to a recording part that is sufficiently small and light to be transported via a conventional transport means for example, and not by way of limitation, the postal service or courier service.
  • a detachable recording part is provided in retro-fit form, i.e. it may be desirable to adapt a pre-existing data collection device to receive a recording part to enable data recording and storage.
  • the assessment device may be manufactured as a single unit.
  • said recording part or device may be attached to an existing data collection part or device to enable data recording.
  • the device may be adapted to allow for electronic download of collected data to a remote site, for example in that it includes a data connection means to enable a communicating connection to a data network site such as an ethernet port, a serial or parallel port for connection to a computer, a port for connection to a wired or wireless telecommunications network for direct download, or any other suitable data connection link.
  • Data transfer ideally will be encrypted to prevent third party access and decoded at a processing facility via responsible healthcare worker.
  • the data connection means also enables download of test protocol data and parameters.
  • test protocol data and parameters would include the time interval between the first and second blood test.
  • the data can be downloaded during an initialization procedure when the test device is first made operable, or download of data can be instigated by a user-initiated operation.
  • the device can be configured, for example, to test blood for gestational diabetes where the test time interval is 1 hour, or test blood for type 1 or type 2 diabetes where the test time interval is at least 2 hours. It should be understood that in practice the device can be configured for any test time interval.
  • the recording device/part includes a microprocessor or other similar electronic device.
  • the recording device is photographic, comprising, for example, a photographic emulsion, the stored images of which are developed at a processing facility. It is envisaged that the device can record data by known analogue photographic means or by known digital means, for example by employing a CCD, a photo detector, a photo-chemical detector or the like.
  • At least one control or calibration is provided in the assessing device.
  • a control conduit may be provided for monitoring flow through the device.
  • Said control conduit may optionally be provided with assay reagents, or alternatively, the elements to be detected by the assay in order to produce a positive result or identification.
  • test device may be fabricated to have a generally planar body, for example being fabricated from planar sheet-like material, which should be taken as to include its being folded, for example for compactness, and in particular being folded prior to use and unfolded for use.
  • a generally planar body for example being fabricated from planar sheet-like material, which should be taken as to include its being folded, for example for compactness, and in particular being folded prior to use and unfolded for use.
  • Any suitable sheet material can be used, and in particular cardboard or plastics material.
  • the sheet material preferably comprises fluid resistant material or is provided with a fluid resistant surface layer or laminated structure.
  • the device is preferably provided with accompanying instructions.
  • An advantage of the sheet-like configuration is that at least some of these instructions may be printed upon a surface of the sheet in order to guide a user as to correct performance of the test protocol.
  • the invention is not limited to a particular construction, and the device may be of any convenient construction, for example folded sheet, moulded plastic casing etc.
  • the glucose tolerance test device comprises an element of a glucose tolerance test kit, being provided in combination with one or more of the following: a standardised glycaemic load; one or more test strips selectively attachable to the device to provide at least a sample collection area of a test zone; one or more lancets to obtain a finger prick sample from a user, for example in the form of a lancing pen; additional instructions for performance of successive tests in accordance with the predetermined protocol.
  • a standardised glycaemic load is preferably provided containing a specific and known amount of a predefined glycaemic substance, for example glucose.
  • the standardised glycaemic load may be in the form of a pre-packaged drink, or in the form of a powder which is to be added to a specified volume of liquid such as water to produce a drink, or incorporated into a solid food stuff.
  • a method of collecting data for performance of at least a data collection phase of a glucose tolerance test comprising the use of a device in accordance with the foregoing.
  • the device of the invention is specifically adapted to implement a particular glucose tolerance testing protocol.
  • a user carries out the following steps: fasts for a specified time period, for example at least eight hours fasting overnight; obtains a test device as above described; obtains a first blood spot sample, for example via a finger prick test by means of a lancet in familiar manner, and adds this sample to a test zone on the test device to obtain a first result; ingests a standardised glycaemic load; optionally following ingestion of a standardised glycaemic load operates a user operable control to indicate the start of a predetermined time interval; waits a predetermined time interval before performing at least one further blood test by obtaining at least one further blood sample, for example via a finger prick test by means of a lancet in familiar manner, and adding this sample to a test zone on the test device to obtain a further result.
  • the method therefore comprises a method to perform a glucose tolerance test using the device of the invention up to the point where raw data is collected and stored in data register.
  • the data is analysed, by comparing test data from the at least two tests, and data concerning the predetermined time interval and/or a measured time interval between the carrying out of at least those two tests, and optionally further data such as described hereinabove, is analysed to produce clinically useful results and for example diagnostic results.
  • the analysis step may be performed domestically by a user with suitable data processing equipment. However, as set out hereinabove, the analysis step is preferably performed remotely and for example under more direct clinical supervision.
  • the method of the invention may include the final step of supplying data collected as above for such a final analysis. In a preferred embodiment of the device, this is achieved in that the device comprises a detachable collecting/recording part, and the method comprises detaching the collecting/recording part and forwarding it to a medical third party for analysis of the stored data and/or processed results. Alternatively, the method comprises forwarding the data for analysis by other means, for example electronically, and for example by downloading the data in the data register by a suitable electronic communication means.
  • the on-board processor of the collecting/recording part includes software or a suitable algorithm to enable the recorded raw test data to be converted into an actual test result(s) that is then stored on the device. Subsequently, the test result(s) can be either displayed to the user via the device display and/or up-loaded to a remote database to which the medical practitioner concerned has access.
  • Figure 1 represents a simple schematic of one possible embodiment of the invention.
  • a device that provides for a test protocol involving two blood tests spaced apart by a suitable time interval at the commencement of which a standard glycaemic load will be ingested is shown. Separate areas are provided for the placement of each test sample. The test areas are included integrally in the device.
  • the glucose tolerance test device thus includes two test areas (18a) and (18b) allowing for discrete application of a blood sample respectively before and after the interval period.
  • Each test area includes an analytical means containing reagents required for the performing of a glucose test.
  • Said analytical means may be in the form of an electrochemical biosensor.
  • the remaining modules are provided for data processing, input and storage. These constitute respectively an electronic controller (11), a data storage register (12) and a data communication controller (13) which together make up an electronic control unit for example in the form of a suitable chip; test indicators in the form of a visual indicator (14) and audible indicator (15); and a data input means (17) to enable the input of additional data about the test.
  • the electronic control unit may include other features such as a clock/calendar function, basic data concerning the protocol etc.
  • Figure 2 illustrates a comparative device, not being an embodiment of the invention.
  • This device provides for a test protocol involving two blood tests spaced apart by a suitable time interval at the commencement of which a standard glycaemic load will be ingested is shown. Separate areas are provided for the placement of each test sample.
  • Most of the components in this schematic representation are equivalent, and like reference numerals are used to refer to them.
  • test zones are provided by removable test strips, respectively (19a) and (19b) for performing tests prior to and subsequent to expiry of the predetermined time period.
  • These strips may be supplied separately, and are attachable to the body of the test device via sockets (20) which receive a portion of the test strip provided with data connectors (21).
  • sockets (20) which receive a portion of the test strip provided with data connectors (21).
  • Each test strip contains reagents required for the performing of a glucose test. Said reagents may be in the form of an electrochemical biosensor.
  • Figure 3 represents an illustration of a specific device of an embodiment of the invention shown in plan view. This embodiment is closer in principle to the schematic representation in Figure 2 , in that it includes removable sample collection areas, although these are in the form of a strips which are originally fabricated integrally but to be torn off after use, rather than strips which are fabricated separately for attachment.
  • the device in this embodiment comprises a laminated cardboard sheet (30).
  • the sheet may be folded prior to use, for example for compactness during storage, but is shown in an unfolded configuration.
  • the sheet has a water resistant surface layer, and includes basic printed instructions on its face which co-operate with features incorporated into the sheet to assist a user in performing the test protocol correctly.
  • the test protocol for this embodiment is a two test protocol, with first and second tests separated by a suitable time interval, the first test performed after fasting, and the second test performed a predetermined time interval after ingestion of a glucose drink.
  • the test device includes suitable control electronics, which are not shown in the representation of Figure 3 , but which would for example parallel those in the previous schematic diagrams, and a suitable power source such as a small battery.
  • the test device includes a start button (34), for example comprising paired opposing conductors which are brought into contact to close a circuit by depression of the button area, which allows a user to start the test.
  • a finger prick blood sample is then applied to a sample receiving area (35a) on a test strip (36a).
  • Adjacent to the strip is an "add sample” indicator LED which illuminates at the start of the test, and a “remove” indicator LED, which illuminates at the end of the test, at which point data has been suitably collected, and the whole strip (36a) can be torn away and discarded via the perforation (37).
  • the user then consumes a glucose drink, and presses a "confirm drink” button (38), again taking the form of paired opposing conductors which serve to close a switching circuit when the button area is depressed.
  • the device in response to either the pressing of the "confirm drink” button or the completion of the first blood test procedure, starts to time the necessary delay period between first and second tests. Progress of this delay period is indicated by successive illumination of LEDs (39), and once the time period has expired an audio alarm (not shown) also sounds.
  • the second blood test is performed by applying a blood sample to a sample receiving area (35b) on a second strip (36b). Again, LEDs indicate when the test should be performed, and when the strip can be removed.
  • test complete LED (40) illuminates and the main portion of the device (3 1) can be forwarded to allow the data to processed.
  • the test strips (36a and 36b) which contain the used blood samples have been removed from the device during the protocol and the device can thus be handled and transported safely in its entirety.
  • the device portion (31) could be further subdivided providing a detachable sub-portion containing a data recording chip or the like, and this can be transported.
  • other ways of processing the raw data collected by the basic device in accordance with the basic method whether by a user or remotely, can be readily envisaged.
  • the test procedure may incorporate the some or all of following actions performed by the present glucose tolerance test device:
  • the test procedure may include a step prior to the provision of the present glucose tolerance test device to a user or other person for the purposes of assessing a particular person's glucose tolerance status by performing a glucose tolerance test on said person wherein:
  • the information recorded by the present glucose tolerance test device maybe retrieved into a database or other form of computer software system for the purposes of:
  • the data may be downloaded to the database in any suitable way, for example by the device facilitating connection by a user to a suitable electronic download means, or by being provided in two parts to allow a data recording part to be physically forwarded to a database manager in the manner above described.
  • a device of the invention facilitates performance by a user in a non-clinical environment and with reduced clinical supervision of a simple standard glucose tolerance test protocol, in order to collect raw data concerning glucose tolerance in a simple and effective manner and in a format which is readily available to a supervising practitioner for subsequent analysis, for example as part of a diagnostic process.
  • the device enables the data necessary for the clinician to make the diagnosis to be collected in a non-clinical environment, for example at home, minimising inconvenience to the patient, and then to be forwarded simply and effectively for subsequent processing, so that clinical intervention is necessary only in performance of those steps where the expertise of the clinician is particularly required.
  • the device can be used within a clinical setting, where the overall test protocol may be supervised by a nurse but where the test device eliminates the requirement for blood samples to be collected and tested or sent for testing by the clinic's personnel, with the test device also administering and controlling the timing of the test protocol and the performing of the blood tests separately for each patient being tested at the clinic.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Optics & Photonics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Claims (15)

  1. Dispositif de collecte de données de test pour tester la tolérance au glucose comprenant :
    une zone de test (18) ayant un moyen pour recevoir au moins des premier et deuxième échantillons de test de sang espacés par un intervalle de temps prédéterminé ;
    une minuterie pour mesurer un tel intervalle de temps, et par exemple pour mesurer le temps écoulé après la collecte dudit premier échantillon ;
    un indicateur (15) pour indiquer au moins qu'un deuxième test est prévu, relié de manière fonctionnelle à la minuterie de façon à fournir une telle indication après écoulement d'un intervalle de temps prédéterminé ;
    un collecteur de données pour collecter des données à partir de la zone de test en relation avec chaque échantillon de test ;
    un registre de données (12) pour stocker des données en relation avec chaque échantillon de test, en communication de données avec ledit collecteur de données ;
    caractérisé en ce que
    ladite zone de test est adaptée par la fourniture d'une pluralité de zones de collecte d'échantillon solidaires pour recevoir au moins deux échantillons de sang sur au moins un intervalle de temps spécifié prédéterminé pour une analyse par ledit collecteur de données.
  2. Dispositif de collecte de données de test selon la revendication 1, dans lequel ladite zone de collecte d'échantillon comprend un puits de collecte d'échantillon pour retenir un tel échantillon de sang in situ pendant l'exécution du test en communication fluidique avec ledit collecteur de données.
  3. Dispositif selon la revendication 1 ou 2, dans lequel la minuterie mesure en outre un premier temps écoulé entre l'exécution d'un test, lorsqu'un premier échantillon est placé dans une zone de collecte d'échantillon, et/ou lorsqu'une commande de début d'intervalle de temps (34) est actionnée, et l'exécution d'un deuxième test, lorsqu'un deuxième échantillon est placé dans une zone de collecte d'échantillon.
  4. Dispositif selon l'une des revendications 1 à 3 comportant une commande de début d'intervalle de temps (34) actionnable par l'utilisateur pour commencer la mesure d'un temps écoulé.
  5. Dispositif selon l'une des revendications précédentes, dans lequel une zone de test comporte un moyen pour détecter la présence d'un échantillon dans une zone de collecte d'échantillon, et ainsi pour permettre l'indication et/ou l'enregistrement du moment de l'exécution d'un test.
  6. Dispositif selon l'une des revendications précédentes, pourvu de, ou adapté pour être placé en communication de données avec, un moyen d'entrée approprié pour introduire des données associées à un test.
  7. Dispositif selon l'une des revendications précédentes, dans lequel ladite pluralité de zones de test (18) comprend une pluralité de modules de collecte d'échantillon détachables (36), un pour chaque échantillon à collecter, initialement comme une partie solidaire du dispositif de l'invention mais adapté pour être enlevé et jeté une fois qu'un échantillon a été traité sur la zone de collecte d'échantillon et que des données ont été collectées à partir de celle-ci par le collecteur de données.
  8. Dispositif selon l'une des revendications précédentes fourni en deux parties, comprenant une partie de collecte de données comportant au moins la zone de test et par exemple également le collecteur de données, et une partie d'enregistrement comportant au moins le registre de données, les deux parties étant en communication de données lors de l'utilisation, mais la partie d'enregistrement de données étant détachable de la partie de collecte de données après utilisation.
  9. Dispositif selon l'une des revendications précédentes, dans lequel le dispositif, ou la partie d'enregistrement de données selon le cas, est adapté(e) pour permettre le téléchargement électronique de données collectées sur un site distant étant donné qu'il/elle comporte un moyen de connexion de données pour permettre une connexion à un site de réseau de données tel qu'un port Ethernet, un port série ou parallèle pour une connexion à un ordinateur, un port pour une connexion à un réseau de télécommunications sans fil ou câblé pour le téléchargement direct, ou toute autre liaison de connexion de données appropriée.
  10. Dispositif selon l'une des revendications précédentes fabriqué de manière à avoir un corps globalement planaire, qui est fabriqué à partir d'un matériau en forme de feuille planaire.
  11. Dispositif selon la revendication 10 pourvu d'instructions d'accompagnement imprimées sur une surface de la feuille afin de guider un utilisateur en ce qui concerne l'exécution correcte d'un protocole de test.
  12. Kit de test de tolérance au glucose, comprenant un dispositif selon l'une des revendications précédentes prévu en combinaison avec un ou plusieurs des éléments suivants :
    une charge glycémique normalisée ;
    une ou plusieurs lancette(s) pour obtenir un échantillon prélevé par piqûre au doigt d'un utilisateur, par exemple sous la forme d'un stylo autopiqueur ;
    des instructions supplémentaires pour l'exécution de tests successifs conformément au protocole prédéterminé.
  13. Utilisation d'un dispositif selon l'une des revendications précédentes pour l'exécution d'un test de tolérance au glucose.
  14. Procédé de collecte de données pour l'exécution d'un test de tolérance au glucose dans lequel un utilisateur effectue les étapes suivantes :
    obtient un dispositif de test selon l'une quelconque des revendications 1 à 11 ;
    jeûne pendant une période spécifiée ;
    ajoute un premier échantillon de tache de sang obtenu de l'utilisateur à une zone de test sur le dispositif de test pour obtenir un premier résultat ;
    ingère une charge glycémique normalisée ;
    éventuellement, après ingestion de ladite charge glycémique normalisée, actionne une commande actionnable par l'utilisateur pour indiquer le début de l'intervalle de temps prédéterminé ;
    attend un intervalle de temps prédéterminé avant d'ajouter un deuxième échantillon de tache de sang obtenu de l'utilisateur après ledit intervalle de temps prédéterminé à une zone de test sur le dispositif de test pour obtenir un autre résultat.
  15. Procédé de la revendication 14, comportant l'étape supplémentaire consistant à fournir des données collectées pour une analyse finale étant donné que le dispositif comprend une partie d'enregistrement de données détachable, et le procédé comprend le fait de détacher la partie d'enregistrement de données et de la transférer pour une analyse des données.
EP08788413.6A 2007-08-23 2008-08-22 Dispositif de test de tolérance au glucose, procédé et utilisation Active EP2180824B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0716427.0A GB0716427D0 (en) 2007-08-23 2007-08-23 Glucose tolerance test device
PCT/GB2008/002853 WO2009024794A1 (fr) 2007-08-23 2008-08-22 Dispositif de test de tolérance au glucose

Publications (2)

Publication Number Publication Date
EP2180824A1 EP2180824A1 (fr) 2010-05-05
EP2180824B1 true EP2180824B1 (fr) 2016-05-04

Family

ID=38599121

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08788413.6A Active EP2180824B1 (fr) 2007-08-23 2008-08-22 Dispositif de test de tolérance au glucose, procédé et utilisation

Country Status (7)

Country Link
US (1) US8420401B2 (fr)
EP (1) EP2180824B1 (fr)
JP (2) JP5613051B2 (fr)
CN (1) CN101835418B (fr)
ES (1) ES2585344T3 (fr)
GB (1) GB0716427D0 (fr)
WO (1) WO2009024794A1 (fr)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9119578B2 (en) 2011-04-29 2015-09-01 Seventh Sense Biosystems, Inc. Plasma or serum production and removal of fluids under reduced pressure
WO2010101626A1 (fr) 2009-03-02 2010-09-10 Seventh Sense Biosystems, Inc. Techniques et dispositifs associés au prélèvement de sang
WO2011065972A2 (fr) * 2009-11-24 2011-06-03 Seventh Sense Biosystems, Inc. Technique d'auto-prélèvement d'échantillons par le patient
US8775095B2 (en) 2010-06-18 2014-07-08 Roche Diagnostics Operations, Inc. Methods and apparatus for decentralized diabetes monitoring
US20130158482A1 (en) 2010-07-26 2013-06-20 Seventh Sense Biosystems, Inc. Rapid delivery and/or receiving of fluids
WO2012021801A2 (fr) 2010-08-13 2012-02-16 Seventh Sense Biosystems, Inc. Systèmes et procédés adaptés pour surveiller des sujets
JP2012177677A (ja) * 2011-02-02 2012-09-13 Arkray Inc 分析装置
EP3106092A3 (fr) 2011-04-29 2017-03-08 Seventh Sense Biosystems, Inc. Systèmes et procédés pour recueillir un fluide provenant d'un sujet
US20130158468A1 (en) 2011-12-19 2013-06-20 Seventh Sense Biosystems, Inc. Delivering and/or receiving material with respect to a subject surface
KR102237667B1 (ko) 2011-04-29 2021-04-12 세븐쓰 센스 바이오시스템즈, 인크. 유체들의 전달 및/또는 수용
US10514385B2 (en) 2011-07-22 2019-12-24 Sysmex Corporation Hematology analyzer, method, and system for quality control measurements
US9317653B2 (en) * 2011-07-22 2016-04-19 Sysmex Corporation Analyzer, and method for performing a measurement on a sample
US9297819B2 (en) * 2011-07-22 2016-03-29 Sysmex Corporation Hematology analyzing system and analyzer
GB2499838A (en) 2012-03-02 2013-09-04 Smartsensor Telemed Ltd Biological test device
WO2013178784A1 (fr) * 2012-06-01 2013-12-05 Sanofi-Aventis Deutschland Gmbh Élément de test facilitant le prélèvement d'un échantillon sanguin
CN103932681B (zh) * 2014-04-13 2016-05-04 曹春杰 出血时间监测仪
ES2926670T3 (es) * 2016-05-13 2022-10-27 Hoffmann La Roche Sistema de medición de analitos y procedimiento de inicialización
WO2018119663A1 (fr) * 2016-12-27 2018-07-05 创新精密仪器有限公司 Procédé de détection du diabète et système de détection du diabète
EP3704466B1 (fr) * 2017-11-01 2023-10-11 The Board of Trustees of the Leland Stanford Junior University Procédé de détection d'analyte
CN112294298A (zh) * 2019-08-02 2021-02-02 华广生技股份有限公司 生物传感器的植入装置及其植入方法
EP4153048A4 (fr) * 2020-05-22 2024-07-31 Abbott Diabetes Care Inc Systèmes, dispositifs et procédés de surveillance d'analyte
US20230138432A1 (en) * 2021-11-01 2023-05-04 Lee Tzong Yann Portable circulatory shock detecting device

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4731726A (en) * 1986-05-19 1988-03-15 Healthware Corporation Patient-operated glucose monitor and diabetes management system
US5837546A (en) * 1993-08-24 1998-11-17 Metrika, Inc. Electronic assay device and method
JP2849809B2 (ja) * 1996-04-23 1999-01-27 株式会社京都第一科学 体液成分を測定するとともにその検査データーを保存管理する装置
JP2002513911A (ja) * 1998-05-06 2002-05-14 アイソテクニカ、インコーポレーテッド 糖尿病症状の診断及び血糖コントロール監視用１３ｃグルコース呼気試験
JP3298008B2 (ja) 2000-02-09 2002-07-02 オムロン株式会社 糖代謝能力判定装置
DE60126448T2 (de) * 2000-04-17 2007-06-14 Nec Corp. Verfahren und System zur Bereitstellung eines heimbasierten Gesundheitsdienstes
WO2002018936A2 (fr) * 2000-08-28 2002-03-07 Cygnus, Inc. Procedes de regulation du niveau de glucose chez un sujet et utilisations de ceux-ci
DE10208575C1 (de) * 2002-02-21 2003-08-14 Hartmann Paul Ag Blutanalysegerät zur Bestimmung eines Analyten
US20030212379A1 (en) 2002-02-26 2003-11-13 Bylund Adam David Systems and methods for remotely controlling medication infusion and analyte monitoring
US20030211617A1 (en) * 2002-05-07 2003-11-13 International Business Machines Corporation Blood glucose meter that reminds the user to test after a hypoglycemic event
US7258673B2 (en) * 2003-06-06 2007-08-21 Lifescan, Inc Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
JP2006071421A (ja) * 2004-09-01 2006-03-16 Nishitomo Co Ltd 生体情報測定装置及び血糖値測定装置

Also Published As

Publication number Publication date
JP2013250283A (ja) 2013-12-12
GB0716427D0 (en) 2007-10-03
US8420401B2 (en) 2013-04-16
ES2585344T3 (es) 2016-10-05
JP2010537185A (ja) 2010-12-02
CN101835418B (zh) 2016-08-03
US20100240079A1 (en) 2010-09-23
EP2180824A1 (fr) 2010-05-05
CN101835418A (zh) 2010-09-15
WO2009024794A1 (fr) 2009-02-26
JP5613051B2 (ja) 2014-10-22

Similar Documents

Publication Publication Date Title
EP2180824B1 (fr) Dispositif de test de tolérance au glucose, procédé et utilisation
US9626480B2 (en) Analyte testing method and system
US5443080A (en) Integrated system for biological fluid constituent analysis
US9851360B2 (en) Self contained in-vitro diagnostic device
JP3905764B2 (ja) 小型検査機器及び精度管理チップ
JP2009543041A (ja) 使い捨て分析装置及び分析方法
JP2002521665A (ja) 複合検査モジュールを有する携帯型瞬時応答医療分析器
JP2012132938A (ja) 試験システム
US11169164B2 (en) System for biological sample collection, examination and reading in quick biochemical tests and data management
US11567093B2 (en) Biological sample reader for biochemical testing
JP2013076598A (ja) 医療機器、エラー情報処理システム及びエラー情報処理プログラム
JPH1038879A (ja) 体液成分を測定するとともにその検査データーを保存管理する装置

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20100209

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR

AX Request for extension of the european patent

Extension state: AL BA MK RS

17Q First examination report despatched

Effective date: 20100715

DAX Request for extension of the european patent (deleted)
RAP3 Party data changed (applicant data changed or rights of an application transferred)

Owner name: SMARTSENSOR TELEMED LIMITED

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

INTG Intention to grant announced

Effective date: 20151124

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: AT

Ref legal event code: REF

Ref document number: 796133

Country of ref document: AT

Kind code of ref document: T

Effective date: 20160515

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 602008044044

Country of ref document: DE

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 9

REG Reference to a national code

Ref country code: NL

Ref legal event code: MP

Effective date: 20160504

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG4D

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2585344

Country of ref document: ES

Kind code of ref document: T3

Effective date: 20161005

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: NO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160804

REG Reference to a national code

Ref country code: AT

Ref legal event code: MK05

Ref document number: 796133

Country of ref document: AT

Kind code of ref document: T

Effective date: 20160504

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160805

Ref country code: SE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160905

Ref country code: HR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160831

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 602008044044

Country of ref document: DE

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: AT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: BE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

26N No opposition filed

Effective date: 20170207

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160831

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160831

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

REG Reference to a national code

Ref country code: IE

Ref legal event code: MM4A

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160822

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 10

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160822

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: HU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO

Effective date: 20080822

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: TR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

Ref country code: MT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20160831

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20160504

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 11

REG Reference to a national code

Ref country code: GB

Ref legal event code: 732E

Free format text: REGISTERED BETWEEN 20200514 AND 20200520

REG Reference to a national code

Ref country code: DE

Ref legal event code: R082

Ref document number: 602008044044

Country of ref document: DE

Representative=s name: NOVAGRAAF BREVETS, FR

Ref country code: DE

Ref legal event code: R081

Ref document number: 602008044044

Country of ref document: DE

Owner name: DIGOSTICS LIMITED, GB

Free format text: FORMER OWNER: SMARTSENSOR TELEMED LTD., ABINGDON, OXFORDSHIRE, GB

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: IT

Payment date: 20230831

Year of fee payment: 16

Ref country code: GB

Payment date: 20230824

Year of fee payment: 16

Ref country code: ES

Payment date: 20230918

Year of fee payment: 16

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20230822

Year of fee payment: 16

Ref country code: DE

Payment date: 20230822

Year of fee payment: 16